Shiley 4UN65ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884521175706), received between Jan 11, 2023 and Oct 30, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BASED ON THE PHOTO PROVIDED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568838 ↗
• MalfunctionOct 30, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THE THREE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BASED ON THE PHOTO PROVIDED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568837 ↗
• MalfunctionOct 30, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BASED ON THE PHOTO PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568645 ↗
• MalfunctionOct 14, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S INNER CANNULA HAD CRACKS BASED ON THE PHOTO PROVIDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446314 ↗
• MalfunctionFeb 1, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD EXPERIENCED A BROKEN TRACHEOSTOMY FLANGE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16277122 ↗
• MalfunctionJan 13, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD EXPERIENCED A BROKEN TRACHEOSTOMY FLANGE PER THE PHOTO PROVIDED TWICE WITHIN 3 MONTHS. THE TRACH WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 16157830 ↗
• MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE TRACH BROKE WHILE IN USE AND RESULTED TO REVERT TO AN OLDER TRACH.

  Patient problems: Unintended Extubation

  MAUDE report 16137957 ↗
• MalfunctionJan 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE WAS BROKEN WHILE IN USE OVERNIGHT. THE PATIENT WAS TURNING HIS NECK WHILE IN BED AND THE TRACH SNAPPED. THE PATIENT WAS REVERTED TO OLDER TRACH.

  Patient problems: Unintended Extubation

  MAUDE report 16137914 ↗